MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K IMPLANT; COCHLEAR IMPLANT

Model Number CI-1400-02H

Device Problems Mechanical Problem (1384); Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 11/11/2019

Event Type  malfunction  

Event Description

The recipient reportedly experienced open electrodes.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the array was severed prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires at the fantail region.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis of the electrode revealed evidence of fatigue breaks.The photographic inspection and scanning electron microscopy analysis revealed all broken electrode wires in the fantail region.It is believed that these breaks caused the multiple electrodes with open circuits.A corrective action was implemented.This is the final.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• MDR Report Key: 9444774
• MDR Text Key: 176491318
• Report Number: 3006556115-2019-00730
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2011
• Device Model Number: CI-1400-02H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR